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Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution | Clinical Trials | Clareo Health

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Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions

NCT04667572•Cornea Associates of Texas

View on ClinicalTrials.gov

Summary

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

Detailed Description

Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, pachymetry, and visual function.

Eligibility

Age

8 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•8 years of age or older
•Signed written informed consent
•Willingness and ability to comply with schedule for follow-up visits
•Contact Lens Wearers Only:
•Removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
•And one or more of the following:
•Presence of central or inferior steepening.
•Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
•Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: Fleischer ring, Vogt's striae, Decentered corneal apex, Munson's sign, Rizzutti's sign, Apical Corneal scarring consistent with Bowman's breaks, Scissoring of the retinoscopic reflex, Crab-claw appearance on topography
•Steepest keratometry (Kmax) value ≥ 47.20 D
+3 more criteria

Exclusion Criteria

•Eyes classified as either normal or atypical normal on the severity grading scheme.
•Corneal thickness \< 300 microns measured by ultrasonic pachymetry or pentacam.
•Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, etc.) Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
•Pregnancy (including plan to become pregnant) or lactation during the course of the study
•A known sensitivity to study medications
•Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
•Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing

Locations (1)

Cornea Associates of Texas

Dallas, Texas, United States

Key Dates

Start Date

February 1, 2021

Primary Completion Date

August 21, 2024

Completion Date

August 21, 2024

Last Updated

February 11, 2025

Enrollment

249

ACTUAL participants

Conditions

KeratoconusPellucid Marginal Corneal DegenerationCorneal DegenerationCorneal Ectasia

Interventions

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

COMBINATION_PRODUCT

PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

NCT07372911

Keratoconus

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RECRUITINGNA

First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

NCT06451718

Keratoconus

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RECRUITING

A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

NCT02118922

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Inclusion Criteria

Exclusion Criteria

PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

Scleral Lens Fitting Using Wide-Field OCT

OCT in Diagnosis of Irregular Corneas